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– SOUTH CAROLINA –
Public and Private Policy
Medical Errors and Patient Safety

Definitions

The DHEC Division of Health Licensing DHL provides regulations [Chapter 61] that include mandates for reporting by 14 different licensed facilities/entities. In general, most of the facility regulations call for reporting and written notification of the DHEC within ten days of the occurrence with reporting of "Accidents/Incidents resulting in death or serious injury."

However, as perusal of the reportable events and their definitions validate, not all facilities provide definitions for the terms "serious injury" or "accidents/incidents." For those facility types that include these definitions, there is variation in definitions with different lists of events identified across facility types.

As a consequence of this lack of standardization, many definitions are ambiguous with no stipulation of any detail and/or listing of events as guidelines to identify events. For example, the definition of reportable events for hospitals does not separately define "serious injury" or "accidents/incidents." The identification of a hospital reportable event is left to the judgment of the reporter. This failure to stipulate or list examples of reportable events undoubtedly accounts for some of the lack of hospital reporting up through 1996, and likely reflects definition ambiguity that persists to the present day.

Also, as mentioned in discussion of regulations, the DHEC did not include licensed abortion clinics, licensed hospices, licensed chiropractic, Freestanding or Mobile Technology, or body piercing facilties in its list of facility types that received the 1996 memorandum [PDF] regarding reportable "Accidents/Incidents." The regulatory descriptions/definitions of events for all 14 facility types are included in the table below, but it is unclear how reporting of accidents and incidents is monitored across all facility/entity types.

For the 14 facility types listed in the table below, not all events that are stipulated for monitoring are reported to the Division of Health Licensing within the DHEC. Reportable events differ slightly by facility type. High-lighted sections of regulation reflect reporting requirements to the DHL.

Definitions of Reportable Events
by Facility Type
DHEC Regulations – Chapter 61

Section / Link Definition Text
Hospitals
Fire Report: A complete written report shall be prepared and promptly submitted to the Department for every fire regardless of size or damage that occurs in the facility.
Accident and/or Incident Report: A record of each accident and/or incident occurring in the facility, including medication errors and adverse drug reactions, shall be retained. Incidents resulting in death or serious injury, e.g., broken limb, shall be reported, in writing, to the Division of Health Licensing within ten days of the occurrence.
Nursing Homes
Accidents/Incidents shall be considered as, but not limited to, medication errors, adverse drug reactions, missing residents, and verbal or written threats to harm the health and welfare of the residents.
Accidents/Incident Reports: A record of each accident and/or incident, involving residents, staff or visitors, occurring in the facility or on facility grounds shall be retained. Accidents/Incidents resulting in death or serious injury shall be reported in writing to the Division of Health Licensing within 10 days of the occurrence.
Serious injuries shall be considered as, but not limited to fractures of major limbs or joints, severe burns, severe lacerations, severe hematomas, and suspected abuse.
Abortion Clinics
Accidents/Incidents A record of each accident or incident occurring in the facility which involves patients, staff, or visitors, including medication errors and adverse drug reactions, shall be prepared immediately. Accidents or incidents resulting in serious injury shall be reported, in writing, to the Department within 10 days of the occurrence; if a death occurs, other than a fetal death, it shall be reported to the Department not later than the next Department work day (Monday through Friday). Accidents and incidents that must be reported include, but are not limited to:
  • 1. Those leading to hospitalization;
  • 2. Those leading to death, other than a fetal death;
  • 3. Adverse drug reactions.
Ambulatory Surgical Facilities
Accidents/Incidents A record of each incident and/or accident, involving patients or staff members, occurring in the facility or on the facility grounds, shall be retained.
  • 1. Serious incidents/accidents and/or medical conditions as defined below and any illness resulting in death or inpatient hospitalization shall be reported via telephone to the next-of-kin or responsible party immediately and in writing to the Department's Division of Health Licensing within 10 days of the occurrence.
  • 2. Serious medical conditions shall be considered as, but not limited to: major permanent loss of function, hemolytic transfusion reaction involving administration of blood or blood products, surgery on the wrong patient or wrong body part, fractures of major limbs or joints, severe burns, lacerations, or hematomas, and actual or suspected abuse or mistreatment of patients.
Fire / Disasters
  • A. The Department's Office of Fire and Life Safety and the Division of Health Licensing shall be notified immediately via telephone or facsimile regarding any fire in the facility, and followed by a complete written report, to include fire department reports, if any, to be submitted within a time-period determined by the facility, but not to exceed 72 hours from the occurrence of the fire.
  • B. Any natural disaster that requires displacement of the patients or jeopardizes or potentially jeopardizes the safety of the patients, shall be reported to the Department's Division of Health Licensing via telephone or facsimile immediately, with a complete written report submitted within a time-period as determined by the facility, but not to exceed 72 hours.
Renal Dialysis Facilities
Incidents and Accident Reports A record of each accident or incident occurring in the facility, including medication errors and adverse drug reactions shall be prepared immediately. Accidents resulting in serious injury or death shall be reported, in writing, to the licensing agency within 10 days of the occurrence. Accidents and incidents that must be recorded include but are not limited to:
  • 1. Those leading to hospitalization;
  • 2. Those leading to death;
  • 3. Use of wrong dialyzer on patient;
  • 4. Blood spills of more than 75 ml.;
  • 5. Hemolytic transfusion reactions;
  • 6. Reactions to dialyzers.
Residential Treatment Facilities for Children and Adolescents
Governing Authority and Management – Administrative Records: The following essential documents and references shall be on file in the administrative office of the facility:
  • (a) appropriate documents showing control and ownership;
  • (b) bylaws, policies and procedures of the governing authority;
  • (c) minutes of the governing authority meetings if applicable;
  • (d) minutes of the facility's professional and administrative staff meetings;
  • (e) a current copy of these regulations;
  • (f) reports of inspections, reviews, and corrective actions taken related to licensure;
  • (g) contracts and agreements related to licensure to which the facility is a party; and
  • (h) a record of each accident or incident occurring in the facility, including medication errors and drug reactions. Incidents resulting in hospitalization or death shall be reported in writing to the Department within 10 days.
Habilitation Centers for the Mentally Retarded
Definitions: "Accident/Incident" shall be considered as, but not limited to, medication errors, adverse drug reactions, missing residents, and verbal or written threats to harm the health and welfare of the residents.
Reports and Records:
  • (a) Accidents/Incident Reports: A record of each accident and/or incident, involving clients, staff or visitors, occurring in the facility or on facility grounds shall be retained. Accidents/Incidents resulting in death or serious injury shall be reported in writing to the Division of Health Licensing within 10 days of the occurrence.
  • (b) Serious injuries shall be considered as, but not limited to, fractures of major limbs or joints, severe burns, severe lacerations, severe hematomas, and suspected abuse.
  • (c) All accidents/incidents shall be reviewed, investigated if necessary and evaluated in accordance with facility policy.
  • (d) Monthly Statistical Record: An accurate and up-to-date monthly statistical record shall be kept and must contain at least the following information: name; case number; age; sex; dates of admission, discharge or death; and days of care rendered during the month.
  • (e) The Department requires each health care facility to annually complete a questionnaire named “Joint Annual Report” and to return this report within the time period as specified in the report's accompanying cover letter.
  • (f) Fire Reports: A complete written report regarding every fire regardless of size or damage that occurs in the facility shall be prepared and promptly submitted to the Department within 10 days of the fire.
Community Residential Care Facilities.
Incidents / Accidents
  • A. A record of each incident and/or accident, including usage of mechanical/physical restraints, involving residents or staff members/volunteers, occurring in the facility or on the facility grounds, shall be retained.
    • 1. Incidents/accidents and/or serious medical conditions as defined below and any illness resulting in death or inpatient hospitalization shall be reported via telephone to the next-of-kin or responsible party immediately and the sponsoring agency at the earliest practicable hour, but not to exceed 12 hours of the occurrence, and in writing to the Department's Division of Health Licensing (DHL) within 10 days of the occurrence.
    • 2. Serious medical conditions shall be considered as, but not limited to: fractures of major limbs or joints, severe burns, severe lacerations, severe hematomas, and actual/suspected abuse/neglect/exploitation of residents.
Incidents / Accidents – missing residents C. Incidents where residents have left the premises without notice to staff members/volunteers of intent to leave and have not returned to the facility within 24 hours, shall be reported to the next-of-kin, sponsoring agency or any agency providing services to the resident and local law enforcement immediately. When residents who are cognitively impaired leave the premises without notice to staff members/volunteers, regardless of the time-period of departure, law enforcement, next-of-kin, and sponsoring agency shall be contacted immediately. DHL shall be notified not later than 10 days of the occurrence.
Fire / Disasters
  • A. DHL shall be notified immediately via telephone or fax regarding any fire in the facility, and followed by a complete written report to include fire department reports, if any, to be submitted within a time-period determined by the facility, but not to exceed 72 hours from the occurrence of the fire.
  • B. Any natural disaster or fire, which requires displacement of the residents, or jeopardizes or potentially jeopardizes the safety of the residents, shall be reported to DHL via telephone/fax immediately, with a complete written report which includes the fire department report from the local fire department, if appropriate, submitted within a time-period as determined by the facility, but not to exceed 72 hours.
Day Care Facilities for Adults.
Incident and Accident Reports: A record of each accident or incident occurring in the facility shall be prepared immediately. Accidents resulting in serious injury or death shall be reported, in writing, to the Department within 10 days of the occurrence.
Hospice
Patient Death: The hospice shall have a written plan to be followed at the time of patient death. The plan must provide for: G. Notification to the Department of any death resulting from an injury, accident, or other possible unnatural causes.
Fire / Disasters:
  • A. The Division of Health Licensing shall be notified immediately via telephone or fax regarding any fire in the hospice facility followed by a complete written report, to include fire department reports, if any, to be submitted within a time-period determined by the hospice facility, but not to exceed 72 hours from the occurrence of the fire.
  • B. Any natural disaster or fire that jeopardizes the safety of any persons in the hospice facility shall be reported to the Division of Health Licensing via telephone or fax immediately, with a complete written report which includes the fire report from the local fire department, if appropriate, submitted within a time-period as determined by the hospice facility, but not to exceed 72 hours.
Chiropractic Facilities
Reports:
  • Section 206.1Fire Report: A complete written and signed report shall be prepared and promptly submitted to the Department of every fire regardless of size or damage that occurs in the facility.
  • Section 206.2Accident and/or Incident Report:A record of each accident and/or incident occurring in the facility shall be retained. Incidents resulting in death or serious injury, e.g., broken limb, shall be reported, in writing, to the Division of Health Licensing within ten days of the occurrence.
    Substance Abuse / Dependency Treatment Facilities
    Incidents / Accidents:
    • A. A record of each accident and/or incident, including usage of physical restraints, involving clients or staff/volunteers, occurring in the facility or on the facility grounds shall be retained.
      • 1. Incidents/accidents and/or serious medical conditions as defined below and any illness resulting in death or inpatient hospitalization shall be reported via telephone to the next-of-kin or responsible person at the earliest practicable hour, but not to exceed 24 hours of the occurrence, and in writing to the Department's Division of Health Licensing (DHL) within 10 days of the occurrence.
      • 2. Serious medical conditions shall be considered as, but not limited to: fractures of major limbs or joints, severe burns, severe lacerations, severe hematomas, and actual/suspected abuse/neglect/exploitation of clients.
    Incidents / Accidents:
    • D. In medical detoxification facilities only, incidents where clients have left the premises without notice to staff/volunteers of intent to leave and have not returned to the facility within 24 hours, shall be reported to DHL, next-of-kin, responsible person, and, if there is evidence that the client may be a danger to himself or others, local law enforcement.
    Incidents / Accidents:
    • F. In NTP facilities, premature or stillborn births to clients shall be reported in writing to DHL within 10 working days.
    Standards for Licensing Freestanding or Mobile Technology
    Incidents / Accidents:
    • A. A record of each accident and incident involving clients or technicians occurring in the facility shall be retained.
      • 1. Serious incidents/accidents and/or medical conditions as defined below and any illness resulting in death or inpatient hospitalization shall be reported via telephone to the next-of-kin or responsible party immediately and in writing to the Department's Division of Health Licensing within 10 days of the occurrence.
      • 2. Serious medical conditions shall be considered as, but not limited to: major permanent loss of function, hemolytic transfusion reaction involving administration of blood or blood products, a procedure on the wrong patient or wrong body part, fractures of major limbs or joints, severe burns, lacerations, or hematomas, and actual or suspected abuse or mistreatment of patients.
    Fire/Disasters: The Department's Office of Fire and Life Safety and the Division of Health Licensing shall be notified immediately via telephone or facsimile regarding any fire occurring at the equipment location and followed by a complete written report to include fire department reports, if any, submitted within a time period determined by the policies and procedures, but not to exceed 10 days from the occurrence of the fire.
    Body Piercing Facilities
    Incidents / Accidents:
    • A. A record of each accident and incident involving clients or technicians occurring in the facility shall be retained. Incidents or accidents resulting in serious medical conditions, e.g., lacerations, hematomas, actual or suspected abuse of clients by technicians, etc., in which the client is hospitalized, shall be reported via telephone to the next-of-kin or responsible person at the earliest practicable hour, but not to exceed 24 hours of the occurrence, and in writing to DHL within 10 days of the occurrence.
    • B. Reports shall contain at a minimum: facility name, technician name, client age and sex, date of incident or accident, location, witness names, identified cause of incident or accident, extent and type of injury and how treated, e.g., hospitalization, and the date of the report.
    Fire / Disasters:
    • A. The facility permit holder shall notify DHL immediately via telephone or fax regarding any fire in the facility, and followed by a complete written report, to include fire department reports, if any, to be submitted within a time-period determined by the facility, but not to exceed 72 hours from the occurrence of the fire.
    • B. Any natural disaster or fire that jeopardizes the safety of any persons in the facility shall be reported to DHL via telephone or fax immediately, with a complete written report which includes the fire report from the local fire department, if appropriate, submitted within a time-period as determined by the facility, but not to exceed 72 hours.

    List of Event Reporting Facility Types

    No. Facility Type
    1 Hospital
    2 Nursing Home
    3 Abortion Clinics
    4 Ambulatory Surgical Centers
    5 Renal Dialysis Facility
    6 Treatment Facilities for Children and Adolescents
    7 Community Residential Care Facilities
    8 Day Care Facilities for Adults
    9 Hospice
    10 Chiropractic Facility
    11 Substance Abuse / Dependency Treatment Facilities
    12 Habilitation Centers for the Mentally Retarded
    13 Freestanding or Mobile Technology
    14 Body Piercing Facilities

    Events Reportable to
    Division of Health Licensing (DHL)
    by Facility Type

    * Facility number / identification in preceding table

    No. / Definition Facility Type – Identified by Number *
    1 2 3 4 5 6 7 8 9 10 11 12 13 14
    1
    Death
    XXXXXXXXXXXXXX
    2
    Serious Injury
    XXXXX XX XXXX 
    3
    Hospitalization
      XXXXX   X XX
    4
    Natural Disaster
       X  X X X  X
    5
    Fire
    XX X  X XXXXXX
    6
    Missing Resident
     X    X   XX  
    7
    Premie/Stillborn Birth
              X   
    8
    Broken Limb / Fracture
    XX X  X XXXXX 
    9
    Medication Errors
    XXXXXXX X XXX 
    10
    Adverse Drug Reactions
    XXXXXXX X XXX 
    11
    Verbal/Written Threats
     X         X  
    12
    Wrong Dialyzer Used
        X         
    13
    Blood Spill >75 ml.
        X         
    14
    Transfusion Reaction
       XX       X 
    15
    Reaction to Dialyzer
        X         
    16
    Laceration/Hematoma
     X X  X X XXXX
    17
    Actual | suspected Abuse
     X X  X X XXXX
    18
    Severe Burns
     X X  X X XXX 
    19
    Major permanent loss of function
       X        X 
    20
    Surgery - wrong patient
       X        X 
    21
    Surgery - wrong body part
       X        X 
    22
    Neglect
          X X X   
    23
    Mechanical/physical Restraints
          XXX X   

    While it is appropriate that some definitions are different because of the different context of healthcare, the difference in reportable events between hospitals and ambulatory surgery centers is less understandable. The ambulatory surgery definition includes some of the JCAHO ‘Reviewable Sentinel Events’, but the hospital definitions do not reflect JCAHO definitons and are non-specific, if not ambiguous.

    Multiple States' experiences suggest widespread provider reluctance to report any event to a regulatory agency, unless the event is explicitly defined. In this regard, South Carolina definitions for hospital events are ambiguous.

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